ORIGEN EL ICD: D050, D051, D052, D053; INOGEN EL ICD: D140, D141, D142, D143; DYNAGEN EL ICD: D150, D151, D152, D1
FDA premarket approval P960040/S373 · decided 2016-06-20
Approval details
- PMA number
- P960040
- Supplement
- S373
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ORIGEN EL ICD: D050, D051, D052, D053; INOGEN EL ICD: D140, D141, D142, D143; DYNAGEN EL ICD: D150, D151, D152, D1
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2016-05-26
- Decision date
- 2016-06-20
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Remove the final finish wetblast manufacturing process step.
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